Kornimate/medical-research-clean huggingface dataset:
linerixibat compassionate use for cholestatic pruritus adult patients with primary biliary cholangitis (pbc)

Conditions: Pruritus

Summary: the goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. this program is for treatment of individuals who have cholestatic pruritus associated with pbc who are deemed at high risk of a significant clinical event as a result of their pruritus and for whom all available pharmaceutical treatment options for cholestatic pruritus have been unsuccessful or are considered to not be appropriate.


Eligibility criteria:
inclusion criteria: * participants with cholestatic pruritus associated to pbc identified by their healthcare provider as being at high risk of a significant clinical event as a result of their pruritus. * male and female \>= 18 years of age. * participants for whom all available pharmaceutical treatments for cholestatic pruritus in pbc have been unsuccessful or are considered to not be appropriate. * contraceptive/barrier requirements (applicable for female participants only): a female participant is eligible if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1. is not a woman of childbearing potential (wocbp) or 2. is a wocbp and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat. exclusion criteria: * advanced chronic liver disease (e.g. cirrhosis child-pugh c) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy). * use of obeticholic acid or other ibat inhibitor.

Keywords: linerixibat individual patient compassionate use primary biliary cholangitis ileal bile acid transporter (ibat) inhibitor
5-year clinical follow-up of restorative materials

Conditions: Dental Caries; Class II Dental Caries

Summary: materials to be used as permanent filling materials in class ii restorations are still an essential field of study. this study aims to evaluate the 5-year clinical performance of class ii restorations performed with different bulk-fill restorative materials. the study was planned as an observational clinical trial. in the study, class ii restorations performed with tetric bulk fill (tbf) and filtek bulk fill (fbf) composites and equia forte fil (ef) will be evaluated. fifty-one patients and 119 restorations will be included in the study. restorations will be assessed in terms of modified united states public health service (usphs) criteria during the 5th year. cochran q, pearson chi-square, and fisher-freeman-halton tests will be used for statistical analysis.


Eligibility criteria:
inclusion criteria: * patients who were; 1. older than 18 years old 2. had good general health and oral hygiene 3. had interface restorations of similar size in their premolars and molars 4. were able to attend control appointments were included the teeth were determined as follows; 1. in contact with the opposing tooth 2. exposed to normal occlusal forces on the dentition 3. restoration width not exceeding 1⁄2 of the intercuspal distance 4. normal response to vitality tests without periodontal pathology exclusion criteria: * patients with; 1. poor oral hygiene 2. those with active periodontal disease 3. those with severe bruxism 4. pregnant and lactating women 5. endodontically treated teeth were excluded from the study
short term effect of vitamin d supplementation on the clinical outcomes in patients undergoing valve replacement surgery

Conditions: Cardiac Valve Replacement Complication

Summary: this study evaluates the effect of vitamin d supplementation on icu and hospital los in patients undergoing valve replacement surgery. half of the patients will receive alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.

vitamin d insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (icu), including cardiac surgical patients. moreover, 25(oh)d levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. vitamin d levels \< 20 ng/ml is associated with higher mortality, infection rates and prolonged length of icu saty. the discovery of vitamin d receptors (vdr) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin d regulates raas activity and cardiac remodeling. the beneficial effects of vitamin d on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.

Eligibility criteria:
inclusion criteria: * patients undergoing mechanical valve replacement surgery exclusion criteria: * combined valvular replacement surgery and coronary artery bypass graft (cabg) surgery * valvular replacement redo * valvular replacement surgery secondary to infective endocarditis * on dialysis * alt levels 2-3 times higher than normal range * chd, * impaired gastrointestinal function * indication for vitamin d supplementation within the prior month * hypercalcemia defined as total calcium \>10.4 mg/dl * hyperphosphatemia defined as serum phosphate \> 4.5 mg/dl * pregnancy and lactation.

Keywords: los mediastinitis secondary myocardial infection
success in comaneci-assist coils embolization surveillance study (success)

Conditions: Intracranial Aneurysm

Summary: the comaneci embolization assist device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. a wide-necked intracranial aneurysm (ia) defines the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. the objective of the postmarket surveillance plan is to assess safety and performance as used in postmarket clinical practice in the u.s.


Eligibility criteria:
inclusion criteria: 1. patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils. 2. patient is considered for treatment with coil embolization assisted by the comaneci device for wide-necked intracranial aneurysms with neck width ≤ 10 mm. a wide-necked intracranial aneurysm is defined by the neck width as ≥ 4 mm or a dome-to-neck ratio \< 2. 3. a signed informed consent by the patient or legally authorized representative exclusion criteria: 1. patient with known hypersensitivity to nickel-titanium

Keywords: rapid medical aneurysm comaneci neurovascular intervention brain
the application of multimodal ultrasound imaging in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome (CTS)

Summary: the aim of this study is to explore the application value of multimodal ultrasound parameters in the diagnosis and treatment follow-up of carpal tunnel syndrome.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years; 2. presence of sensory abnormalities and motor dysfunction in the median nerve distribution area; 3. positive tinel's sign or phalen's test; 4. neurophysiological examination consistent with mild to moderate carpal tunnel syndrome.- exclusion criteria: 1. severe carpal tunnel syndrome; 2. concurrent rheumatic, metabolic, systemic, or other systemic diseases; 3. concurrent cervical spondylosis or other peripheral neuropathies; 4. wrist joint trauma, surgery, space-occupying lesions, or nerve itself with space-occupying lesions; 5. concurrent malignant tumors or severe cardiopulmonary diseases; 6. history of previous wrist surgery or injections; 7. pregnancy; 8. allergy to corticosteroids or local anesthetics.-

Keywords: ultrasound
chest ct with iterative reconstruction as an alternative to conventional chest x-ray prior to heart surgery

Conditions: Cardiac Defects; Disorder; Heart, Functional, Postoperative, Cardiac Surgery; Stroke

Summary: to assess if information about aortic calcification obtained from routine preoperative ultra low-dose chest ct lowers the postoperative stroke rate in patients undergoing heart surgery by optimizing surgical strategy compared to the normal work-up with a conventional chest x-ray.

during heart surgery the aorta is clamped to initiate cardiopulmonary bypass. this may crush aortic calcifications causing them to embolize to the brain causing a stroke which is a devastating complication for the patient. a chest x-ray is routinely performed prior to heart surgery. it provides no information about aortic calcification. imaging by a chest computed tomography (ct) scan provides detailed information on aortic calcification but has higher radiation exposure and thus is not used routinely. recently iterative reconstruction (ir) techniques have become available that allow chest ct to be performed at markedly reduced dose with retained image quality. routine use of low dose chest ct with ir prior to heart surgery may identify patients with a severely calcified aorta in which the surgery may subsequently adapted to minimize or avoid aortic manipulation which may reduce stroke rate. in this multicenter randomized controlled clinical trial the effect of preoperative chest ct on postoperative stroke is investigated. in total 1724 patients will be included of whom 862 patients will receive an additional ct to standard care and 862 patients will receive routine care.

Eligibility criteria:
inclusion criteria: * 18 years old or older * scheduled to undergo heart surgery * provide written informed consent exclusion criteria: * patient not meeting inclusion criteria * pregnant women * scheduled to undergo transcatheter aortic valve insertion procedure (since these patients receive a standard preoperative ct) * chest or cardiac ct in the past three months * emergency surgery * concomitant or previous participation in a study that prohibits the patient from participating in a study that exposed the patient to radiation * unwillingness to be informed about unrequested findings on the ct scan
using behavioral therapy in combination with darifenacin for symptoms of overactive bladder

Conditions: Urinary Incontinence

Summary: this study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.


Eligibility criteria:
inclusion criteria: * symptoms of overactive bladder * capable of independent toileting and completing a micturition diary * able to comprehend english and follow study procedures and instructions exclusion criteria: * post void residual \> 100ml/sec * urine flow rate (qmax) \<10ml/sec for males only other protocol-defined inclusion/exclusion criteria may apply

Keywords: oab overactive bladder bladder hyperactivity urge incontinence incontinence bladder
the osteoarticular manifestations in patients with gitelman syndrome

Conditions: Gitelman Syndrome; CPPD - Calcium Pyrophosphate Deposition Disease

Summary: patients with clinically and genetically confirmed gitelman syndrome are screened for cppd, and the clinical and radiographic manifestations are collected and analyzed.

patients with clinically and genetically confirmed gitelman syndrome are screened for calcium pyrophosphate deposition, and the clinical data and radiographic manifestations are collected and analyzed to investigate the osteoarticular features in patients with gitelman syndrome.

Eligibility criteria:
inclusion criteria: * patients confirmed with gitelman syndrome exclusion criteria: * patients with other confounding situations such as bartter syndrome, hyperparathyroidism
unicompartmental knee arthroplasty vs high tibial osteotomy.

Conditions: Knee Osteoarthritis; Knee Arthroplasty

Summary: valgus high tibial osteotomy (hto) and unicompartmental knee arthroplasty (uka) are established treatment options for patients with medial compartmental osteoarthritis (oa) of the knee.however, the clinical outcomes of these treatment modalities for unicompartmental oa have become subjects of debate.

although hto for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after hto is greater than that after uka . as compared with hto, uka has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. furthermore, indications for uka are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.

Eligibility criteria:
inclusion criteria: 1. - medial compartment osteoarthritis with exposed bone on both femur and tibia. 2. -functionally intact anterior cruciate ligament (superficial damage or splitting is acceptable) 3. -full thickness and good quality lateral cartilage present 4. -correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-medically fit showing an american society of anesthesiologists (asa) of 1 or 2 exclusion criteria: 1. require revision knee replacement surgery. 2. have rheumatoid arthritis or other inflammatory disorders. 3. are unlikely to be able to perform required clinical assessment tasks. 4. have symptomatic foot, hip or spinal pathology. 5. previous knee surgery other than diagnostic arthroscopy and medial menisectomy. 6. previously had septic arthritis. 7. have significant damage to the patella-femoral joint especially on the lateral facet.

Keywords: unicompartmental knee replacement
identification of new genetic markers for the risk of recurrence of venous thromboembolism by whole genome analysis

Conditions: Venous Thromboembolism (VTE)

Summary: venous thromboembolism (vte) is a common and potentially fatal pathology in france. the risk of recurrence is around 5 to 7% per year. the identification of patients at risk of vte and its prevention is a real health issue in particular. 50% of mtev recurrences occur in the absence of a risk situation, suggesting the involvement of specific risk factors for mtev recurrence that have not been identified to date. in the last ten years, so-called "genome-whole" or "genome wide" association (gwas) approaches have identified new genetic risk factors for the first episode of vte. on the other hand, no study has focused on the predictive factors of recurrence. the previous project, conducted from 2012 (nct02904967), had as its main objective to identify new genes for susceptibility to mtev recurrence by comparing cases of mtev recurrence versus controls having had a single episode of mtev. the martha cohort (1,542 patients) is extremely valuable study material and is one of the few cohorts in the world with genome-wide data in the field of vte. follow-up could only be performed in 359 patients, 76 (21%) of whom presented with a new episode of vte. the objective of this project is to increase the number of patients for whom the investigators will have information on recurrence / non-recurrence of vte, by querying national registries on the vital status of patients, and possible causes of death. . these new data on the occurrence or not of a new thrombotic episode, will be confronted with the genetic data already available in all the patients in order to identify specific genetic risk factors and potentially predictive of the recurrence of mtev.


Eligibility criteria:
inclusion criteria: * patients of the martha cohort exclusion criteria: * none
an eight-week study evaluating the efficacy of a 100mg dose of saredutant once daily, in elderly patients with major depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of the study is to evaluate the efficacy of saredutant in the treatment of major depressive disorder in elderly patients.to evaluate the tolerability, safety and efficacy on disability and quality of life in patients with major depressive disorder.to evaluate safety and tolerability of 24 weeks of additional treatment in patients completing the initial 8-week treatment period.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder, recurrent, as defined by diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (296.3) and confirmed by the semi-structured mini international neuropsychiatric interview (mini). exclusion criteria: * total score of less than 23 on the madrs. * ham-d total score less than 17. * duration of the current depressive episode less than 1 month or greater than 2 years. * patients with an mini mental state examination score of less than 23. * patients with a history or presence of bipolar disorders or psychotic disorders. * patients with alcohol/substance dependence or abuse in the past 12 months except nicotine or caffeine dependence. * patients who have used the following prior to entry into acute phase: antipsychotics within 3 months, fluoxetine within 1 month, monoamine oxidase inhibitors within 4 weeks, other antidepressants, or mood-stabilizer (lithium, anticonvulsants) within 1 week. the investigator will evaluate whether there are other reasons why a patient may not participate

Keywords: depression major depressive disorders controlled clinical trial
a study of blosozumab (ly2541546) in postmenopausal female participants

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (sc) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (pmp) female participants. information about any side effects that may occur will also be collected. this study will also be looking for special markers called "biomarkers" that can be used to study osteoporosis and/or the effects of the study drug. there will be 2 parts to this study. the first part will last approximately 6 weeks and the second part will last approximately 7 weeks.


Eligibility criteria:
inclusion criteria: * part a: overtly healthy pmp females * part b: pmp women who are currently taking oral bisphosphonates * have a body mass index (bmi) at screening of 19.0 to 35.0 kilogram per square meter (kg/m\^2) exclusion criteria: * show evidence of human immunodeficiency virus (hiv) infection and/or positive human hiv antibodies * show evidence of hepatitis c and/or positive hepatitis c antibody * show evidence of hepatitis b and/or positive hepatitis b surface antigen * have known allergies to blosozumab, its constituents, or related compounds * have an abnormality in the 12-lead electrocardiogram (ecg)
peripheral microvascular resistance as a predictor for limb salvage

Conditions: Peripheral Arterial Disease

Summary: salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. it is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. however, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography. in the coronary circulation, coronary flow reserve (cfr) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. the study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.


Eligibility criteria:
inclusion criteria: * chronic critical limb ischemia (rutherford 4-6). * age ≥18 years * ability and willingness to sign the irb approved informed consent form exclusion criteria: * non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible. * non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical rutherford 6 patients). * inability to understand the study or a history of non-compliance with medical advice; * history of any cognitive or mental health status that would interfere with study participation; * currently enrolled in any pre-approval investigational study. * female subjects who are pregnant or nursing or planning to become pregnant within the study period; * known sensitivity to contrast media, which can't be adequately pre-medicated; * expected life span less than 6 months. * unable to read/understand/sign the english language consent form

Keywords: microvascular disease microvascular resistance limb salvage peripheral arterial disease critical limb ischemia
anxiety assessment before regional anesthesia.

Conditions: Anxiety Regional Anesthesia Pre-operative

Summary: we want to assess the level of anxiety of patients who arrive in the operating room before performing regional anesthesia.

when patients arrive in the operating room, we want to submit them a validated questionnaire (apais score and stai-6 score) to assess their anxiety. after that, the care (anesthesia and surgeries) will take place in a very usual way and similar to our standards of care.

Eligibility criteria:
inclusion criteria: * patient\> 18 years * surgery performed under general anesthesia or not but preceded by a regional anesthesia. exclusion criteria: * refusal of the patient * psychiatric disorders (pathological anxiety, psychosis, depression) * language barrier * major drug impregnation.
esophagectomy in patients with liver cirrhosis

Conditions: Esophageal Cancer; Liver Cirrhosis

Summary: retrospective and confounder adjusted comparison of perioperative and longterm outcomes of patients requiring an esophagectomy for esophageal cancer with and without concomitant liver cirrhosis.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * primary esophageal cancer with indication for curative treatment * follow up period ≥ 5 years * lc cohort: pre- or intraoperative histological proof of liver cirrhosis exclusion criteria: * recurrent esophageal cancer * missing indication for curative treatment of esophageal cancer * esophagectomy for benign esophageal lesions

Keywords: esophagectomy